Advanced Auto Trends, Inc.
QUALITY MANUAL
ISO 9001:2008 / TS 16949:2009
May 25, 2016
Rev. Level: 10
Contents
Section Page
- Quality Policy and Mission 3
- Objectives
- Scope
- Exclusions and Justifications to Standard
- AATI Organization Chart 4
4.0 Quality Management System 6
- 4.1 General Requirements 6
- 4.2 Documentation 7
5.0 Management Responsibility 9
- 5.1 Management Commitment 9
- 5.2 Customer Focus 10
- 5.3 Quality Policy 10
- 5.4 Planning 10
- 5.5 Responsibility, Authority and Communication 12
- 5.6 Management Review 15
6.0 Resource Management 15
- 6.1 Provisions and Resources 15
- 6.2 Human Resources 16
- 6.3 Infrastructure 17
- 6.4 Work Environment 18
7.0 Product Realization 18
- 7.1 Planning 18
- 7.2 Customer-Related Processes 19
- 7.3 Design and Development 19
- 7.4 Purchasing 20
- 7.5 Product and Service Provisions 22
- 7.6 Control of Monitoring and Measurement Devices 25
8.0 Measurement, Analysis and Improvement 26
- 8.1 General 26
- 8.2 Monitoring and Measurement 27
- 8.3 Control of Nonconforming Product and Rework 29
- 8.4 Analysis and Use of Data 30
- 8.5 Improvement 31
- Manual Revision Control (History) 35
Quality Policy and Mission
Quality Mission/Policy
: The focus of Advanced Auto Trends, Inc. is to realize financial success and provide employment in the local community for many years to come. AATI is committed to meeting and exceeding our customer’s requirements and expectations through our commitment to the ISO9001:2008 / TS 16949:2009 standard. Furthermore, by concentrating our resources on efficiency in our operations, attention to detail, and through teamwork and a commitment, we will endeavor to continually improve our products and processes, ultimately retaining continual customer satisfaction.
Quality Statement (Slogan)
Advanced Auto Trends, Inc. is committed to Quality through Teamwork, Pride and Continuous Improvement.
Objectives
· Using quality and promptness as the two main determining factors in selection and monitoring of our suppliers.
· Determining baseline measured criteria for current efficiencies and then improving them annually.
· Removing wasted or non-value added steps and time in our processes where feasible.
· All new fixtures are to include sensors and poke-yoke systems where feasible.
Scope
Manufacture of plastic injected molded parts, metal stampings and assemblies.
Exclusions & Justifications to Standard
Advanced Auto Trends, Inc., takes exclusion to the following sections: 7.3 Design and Development. 7.3.1 Design and development planning, 7.3.1.1 Multidisciplinary approach, 7.3.2, 7.3.2.1, 7.3.3, 7.3.3.1, 7.3.4, 7.3.4.1 Design and development review, monitoring, 7.3.5 Design and development verification and 7.3.6, 7.3.6.1 Design and development validation.
Advanced Auto Trends, Inc. takes the above exclusion and the justification: Where we provide design assistance, any and all assistance is provided and addressed in the APQP process. All documents and records are maintained and retained electronically and hardcopy, during and throughout the entire APQP process.
KEY PERSONNEL
May ‘2016
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4.0 Quality Management System
Referenced procedures: Document and Data Control Engineering, Document Control, Control of Records
4.1 – 4.1.1 General requirements
a) It is the responsibility of the Management Representative to:
· Ensure that the quality management system of Advanced Auto Trends, Inc. is established, documented as required, implemented, managed and maintained according to the requirements of ISO9001:2008 / TS 16949:2009
· Continual improveimprovement the effectiveness of the quality management system
· Are operational and administrative activities affecting quality of the departments, e.g. Engineering, Manufacturing, Quality, Purchasing, Warehouse, Tool room, Sales and Customer Service and Quality Management System Administration are in compliance with ISO9001:2008 / TS 16949:2009
b) It is the responsibility of the Management Representative and the department heads to ensure that the activities/processes included in the scope of the quality management system are identified and are performed in compliance with ISO9001:2008 / TS 16949:2009
c) It is the responsibility of the Management Representative and department heads to ensure that the sequence and interaction of processes or activities of this quality management system are determined in a suitable manner, such as quality plans, flow charts, operating procedures, etc.
d) It is the responsibility of the Management Representative and department heads to apply the necessary techniques and criteria in order to verify that established processes/activities and their implemented controls are effective.
e) It is the responsibility of the Plant Managers, Management Representative and other department heads to ensure that the necessary human and material resources as well as the necessary information are available to ensure the effective operation and control of the processes of the quality management system.
f) It is the responsibility of the Management Representative and department heads to ensure that the processes/activities, which are part of the quality management system, are monitored, measured and analyzed regarding their achievement of planned results.
g) As required, the Management Representative and department heads ensure that action is taken to obtain expected results of processes/activities, as well as the continual improvement of these processes/activities.
In the event that processes, which do affect product conformity, are outsourced, Quality establishes and implements the necessary controls for approval processes to ensure conformance to specified requirements. These implemented controls however, do not absolve Advanced Auto Trends, Inc. from the responsibility of supplying products and service that meet customer requirements. (ISO 9001:2008 / TS 16949:2009)
4.2 Documentation Requirements
4.2.1 General
As a minimum, the documentation of Advanced Auto Trends, Inc. quality management system includes:.
· A quality policy and objectives
· A quality manual
· Required documented procedures (per ISO/TS16949), for clauses: 4.2.3 Control of Documents; 4.2.4 Control of Records; 6.2.2.2 Training; 8.2.2 Internal Audit; 8.3 Control of Nonconforming Product; 8.5.2 Corrective Action and 8.5.3 Preventive Action
· Other documents which are necessary for the effective planning, operation and control of processes of the quality management system.
· Records required by ISO9001:2008 and by Advanced Auto Trends, Inc. to ensure appropriate control and evidence of compliance with requirements.
The document structure of Advanced Auto Trends, Inc. quality management system consists of fourthree criteria:
1) The Quality Manual, describing the quality management system of AATI and its compliance with ISO9001:2008 / TS 16949:2009
2) Supplier Quality Manual, describing supplier requirements to AATI.
3) Operating procedures, work instructions, forms, master lists, operating instructions, quality plans, control plans and other necessary documents for the effective and efficient operation of the quality management system.
4) Any external documents necessary that ensure compliance to customer and/or national / international standards, e.g., all relevant supplier PPAP documents; AIAG reference manuals; ASQ national standards, etc. (ISO 9001:2008)
· In addition, records are created as required by ISO9001:2008 / TS 16949:2009, as well as records necessary to meet other internal and external requirements.
It is the responsibility of the Management Representative to ensure the availability of companycorporate documents of the quality management system and documents required by ISO9001:2008 / TS 16949:2009. It is the responsibility of the department heads to ensure the development and availability of documented procedures, work instructions, operating instructions and any other documents related to their departments, and which are necessary to ensure the effective implementation, control and functioning of the quality management system and its processes.
4.2.2 Quality Manual
This Quality Manual includes the Scope of the Quality Management System and applicable permissible exclusions from the requirements of ISO9001:2008 / TS 16949:2009 and their justification makes reference to applicable operating procedures and other pertinent documents. The following is a description of the interaction of processes of the Quality Management System.
4.2.3 Control of Documents
Documents required by the quality management system are controlled documents. It is the responsibility of the Management Representative to implement and maintain the documented procedure Control of Documents, which defines the responsibilities for the development of controlled documents, their approval for adequacy, changes and re-approval, revision status, document formats, identification codes and distribution. This includes all necessary external documents required to ensure compliance to the quality management system. (IS0 9001:2008)
4.2.3.1 Engineering Specifications
Following the documented procedure Document and Data Control, the Engineering department is responsible for the identification, control and distribution of technical engineering documents, including documents and data of external orgin such as standards and customer drawings. Engineering documents developed by Engineering or engineering documents from the customer, including the distribution of these documents, are recorded. Incoming customer engineering standards and specifications, including changes, are reviewed as soon as possible by Engineering, and are then distributed and implemented as required. Records of implementation dates in production are maintained.
It is the responsibility of the applicable department head to ensure that current revisions of controlled documents are legible, readily available where needed, that obsolete copies are replaced and destroyed or invalidated, and that obsolete documents retained for any purpose are clearly identified.
Computer Backups:
Backups of the overall computer systems are conducted frequently.
- All company data are backup hourly and daily.
- The method used to backup data on storeage arrays, is disc to disc deduplication with periodic snapshot replicas.
- Data are also replicataed to an off-site location on an hourly basis.
- Email backups are performed twice daily.
4.2.4– 4.2.4.1 Control and Retention of Records
Records are maintained to provide evidence of activities and their results, of conformance to requirements and of the effective operation of the quality management system. Department heads are responsible for the proper identification, storage, retrieval, protection, retention time and disposition of records according to the established documented procedure.
Reference Procedures: Regulatory Requirements, Compliance, Training, and Customer Satisfaction Measurement.
5 Management Responsibility
5.1 – 5.1.1 Management Commitment – Process Efficiency
The management of AATI is committed to the development, implementation and well functioning of the quality management system and the continual improvement of its effectiveness. In order to provide this evidence, the Management Representative ensures that:
· a companycorporate quality policy is established
· quality objectives are established by selected departments
· The importance of meeting customer requirements and statutory and regulatory requirements is part of the training of each employee.
· Resources for the implementation and maintenance of the quality management system and its processes are provided in a timely manner.
· At a minimum, yearly management reviews are conducted to verify the effectiveness, efficiency and proper functioning of the quality management system, including product realization processes and support processes. Monthly reviews are conducted to address current KPI's.
5.2 Customer Focus
The Management Representative, Plant Managers and other department heads, ensures that procedures for determining and meeting customer requirements are established and implemented by the responsible departments. The effectiveness of these procedures is discussed, as necessary, during weekly management meetings. Key Measureables (KPI's) are also part of the measurement activities and reviewed monthly.
5.3 Quality Policy
The management of AATI has developed a companycorporate quality policy, which meetmeets the needs of AATI and its customers.
It is the responsibility of AATI’s management to implement and maintain this quality policy. The quality policy includes AATI’s commitment for continual improvement, for meeting internal requirements and customer requirements, and provides a basis for the establishment and review of quality objectives. The quality policy is made known within the organization and understood and adhered to by employees. During management reviews, the quality policy is reviewed for its continuing suitability.
5.4 Planning
5.4.1 – 5.4.1.1 Quality Objectives
General
Each year, management defines quality objectives and measurements, which are included in the business plan. In addition, department heads for their departments establishes yearly quality objectives. Management approves these departmental quality objectives.
Established quality objectives are consistent with the quality policy, included, as appropriate, are objectives to meet product requirements (see 7.1.a), and are defined in such a way that their degree of achievement and results can be measured.
At least two quality objectives of the departments Manufacturing, Quality and Technical Service are related to the performance of product and/or service.
The completion and achievement of yearly quality objectives included in the business plan and departmental quality objectives are reviewed during management review regarding their level of achievement.
CompanyCorporate quality objectives
Based on the companycorporate quality policy, the management of AATI has established the following corporate quality objectives:
· Using quality and promptness as the two main determining factors in selection and monitoring of our suppliers.
· Determining baseline measured criteria for current efficiencies and then improving them annually.
· Removing wasted or non-value added steps and time in our processes where feasible.
· All new fixtures are to include sensors and poke-yoke systems where feasible.
Based on internal and external audit results, these company quality objectives are reviewed during management reviews to discern their continuing suitability.
5.4.2 Quality Management System Planning
Annually, the company hasManagement Representative calls for a meeting with all managementof the department heads, with the purpose to review, coordinate and plan the efficiency and effectiveness of the quality management system and the realization of established quality objectives of the departments, as well the coordination of improvement opportunities. The General Requirements of clause 4.1 of ISO9001:2008 / TS 16949:2009 are included in this planning process.
The output of these planning activities includes the identification of required resources. As appropriate, results from audits of the quality management system as well as permissible exclusions according to ISO9001/2008 / TS 16949:2009 are considered. Planning activities are documented and are consistent with other requirements of the quality management system.
It is the responsibility of the Management Representative to ensure that resulting organizational changes and their consequences are identified and defined. The changes resulting from planning activities are coordinated and implemented in a controlled manner, that changes to the quality management system are documented, implemented and approved, and that the quality management system is properly maintained during these changes.
Note: Quality planning for manufacturing processes and service activities is performed by the Quality Planning Team under the responsibility of the Engineering department.